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Phase 3 Completed N=183 Randomized Quadruple-blind Supportive Care

Superficial, Cervical Block in Thyroid Surgery, a Randomized Controlled Trial

Source: ClinicalTrials.gov NCT00472446 ↗
Enrolled (actual)
183
Serious AEs
0.6%
Results posted
Sep 2016
Primary outcomePrimary: Post-operative Pain Measured by Visual Analogue Scale — 2.15; 2.02; 2.84; 2.72 units on a scale — p=.028
◆ Published Evidence
Established
44citations · ~3 / year
Randomized controlled trial of bilateral superficial cervical plexus block versus placebo in thyroid surgery.
The British journal of surgery · 2010 · Open access · High-confidence link

Summary

The study investigates the impact on post-operative pain of the superficial cervical block with bupivacaine combined with subcutaneous infiltration of the incisional area in thyroid surgery under general anesthesia. In addition, cost savings using the cervical block are evaluated (due to reduced length of hospital stay). The study is prospective, randomized, double blind, and placebo-controlled. The study is performed at the Department of Surgery, Cantonal Hospital of St. Gallen.

Linked Publications

  • Randomized controlled trial of bilateral superficial cervical plexus block versus placebo in thyroid surgery.
    The British journal of surgery · 2010 · 44 citations · Open access · High-confidence link

Outcome Measures

OutcomeResultp-value
PRIMARY
Post-operative Pain Measured by Visual Analogue Scale
1.95; 1.51; 2.20; 2.06
PRIMARY
Pooled Relative Treatment Effect of VAS
0.47; 0.45; 0.55; 0.54 0.016 sig
SECONDARY
Post-operative Pain Measured by Visual Analogue Scale
1.95; 1.51; 2.20; 2.06
SECONDARY
Consumption of Post-operative Analgetics
21; 23; 18; 24; 6; 7 0.94
SECONDARY
Mean Consumption of Post-operative Analgetics
3.33; 3.37; 4.06; 4.33; 1.25; .93 0.328
SECONDARY
Hospital Stay
1.8; 1.6; 2.0; 1.6 0.925

Eligibility Criteria

Inclusion Criteria

  • Elective thyroid or combined thyroid/parathyroid surgery, restricted to the central cervical compartment
  • Informed consent

Exclusion Criteria

  • Intolerance to used medication
  • Recurrent disease
  • Neck dissection, sternotomy
  • Emergency surgery
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00472446) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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